Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers (IMPRESS)

October 16, 2024 updated by: Imperial College London
Patients with suspected or proven sigmoid colon adenocarcinoma, eligible for curative treatment whose MRI can be reviewed prior to surgery and has no decision regarding radical treatment are eligible. Patient are randomised to the control arm which the standard care of preoperative CT imaging and subsequent discussion by the Multidisciplinary Team or the interventional arm which has the additional use of MRI imaging and subsequent discussion by the Multidisciplinary Team. Patients are followed up at 1 and 3 years together with QoL questionnaires.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A randomised phase II multicentre trial, IMPRESS will determine whether the use of MRI imaging in staging sigmoid cancers results in a change to the treatment plan by identifying more high risk tumours compared to those patients who were staged using CT imaging. The proposed intervention will be additional radiological and pathological assessment and the reporting of supplementary diagnostic information which would not otherwise have been available. This may affect treatment according to local MDT protocols and also affect the provision of prognostic information to patients in subsequent discussions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
244

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Huntingdon, Cambridgeshire, United Kingdom, PE29 6NT
    • Cheshire
    • County Durham
      • Stockton-on-Tees, County Durham, United Kingdom, TS19 8PE
        • Recruiting
        • University Hospital of North Tees
        • Contact:
        • Principal Investigator:
          • Anil Agarwal
    • Croydon
      • Thornton Heath, Croydon, United Kingdom, CR7 7YE
    • Derbyshire
      • Chesterfield, Derbyshire, United Kingdom, SS4 5BL
        • Recruiting
        • Chesterfield Royal
        • Contact:
        • Principal Investigator:
          • Harjeet Singh Narula
    • Hampshire
    • Harrow
      • Middlesex, Harrow, United Kingdom, HA1 3UJ
    • Kent
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • Recruiting
        • Maidstone Hospital
        • Contact:
        • Principal Investigator:
          • Sukanya Ghosh
      • Margate, Kent, United Kingdom, CT9 4AN
        • Recruiting
        • Queen Elizabeth the Queen Mother Hospital
        • Contact:
        • Principal Investigator:
          • Jess Evans
    • Manchester
      • Crumpsall, Manchester, United Kingdom, M8 5RB
      • Wythenshawe, Manchester, United Kingdom, M23 9LT
    • North Yorkshire
      • Harrogate, North Yorkshire, United Kingdom, HG2 7SX
        • Recruiting
        • Harrogate District Hospital
        • Contact:
          • David Leinhardt
        • Contact:
        • Principal Investigator:
          • David Leinhardt
    • Somerset
      • Taunton, Somerset, United Kingdom, TA1 5DA
        • Recruiting
        • Musgrove Park Hospital
        • Contact:
        • Principal Investigator:
          • Erica Beaumont
      • Yeovil, Somerset, United Kingdom, BA21 4AT
        • Active, not recruiting
        • Yeovil District Hospital
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital
        • Contact:
        • Principal Investigator:
          • Irene Chong, MD
    • Whiltshire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Have a suspected or proven sigmoid colon adenocarcinoma
  2. Is eligible for curative treatment
  3. Has no irresectable metastatic disease
  4. MRI can be reviewed by an MDT prior to surgery
  5. Has no decision regarding radical treatment
  6. Have provided written informed consent to participate in the study
  7. Be aged 16 years or over

Exclusion Criteria:

  1. Have metastatic disease (including resectable liver metastases)
  2. Have a synchronous second malignancy
  3. Are contraindicated for MRI
  4. Are contraindicated for or have allergy to Buscopan (e.g. glaucoma, small or large bowel obstruction, GFR<30)
  5. Have severe co-morbidities or previous medical history that prevent the application of eventual chemo/radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Preoperative CT scan
CT-imaging of chest and abdomen / pelvis before surgery (standard treatment)
Experimental: Preoperative MRI scan
Standard treatment plus an additional MRI scan before surgery
Other: Preoperative MRI scan
Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.
No Intervention: Observational
Observational only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Observational Phase: To measure the difference in staging of sigmoid cancer on CT and MRI.
Time Frame: 3 years after last recruit
Direct comparison of proportion of patients staged as high and low risk for recurrence between CT vs MRI findings
3 years after last recruit
Randomised Phase: To measure the difference in treatment stratification policy caused by the difference in staging on CT and MRI.
Time Frame: 3 years after last recruit
Direct comparison of proportion of patients undergoing preoperative treatment or extended surgery between patients staged with CT vs MRI
3 years after last recruit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To compare the recurrence rates of sigmoid tumours staged by CT and MRI according to predicted prognostic risk.
Time Frame: 3 years after last recruit
Comparison of proportion of recurrences in patients staged as low vs high risk on CT vs MRI
3 years after last recruit
To compare disease free survival of patients staged by CT and MRI according to predicted prognostic risk.
Time Frame: 1 and 3 years after last recruit
Kaplan-Meier curves of disease free survival in patients staged as low vs high risk on CT vs MRI
1 and 3 years after last recruit
To compare the quality of surgery by pathology of patients staged by CT and MRI according to predicted prognostic risk.
Time Frame: 5 years
Grade of specimen using pathology TNM8 stratified by TNM8 staging on CT vs MRI
5 years
To compare CRM positivity rates on pathology of patients staged by CT and MRI according to predicted prognostic risk
Time Frame: 3 years after last recruit
CRM positivity rates on pathology in patients staged as low vs high risk on CT vs MRI
3 years after last recruit
To compare baseline and post-treatment stage on imaging against pathology and clinical outcomes of patients staged by CT and MRI.
Time Frame: 3 years after last recruit
Comparison of proportion of patients staged as low vs high risk on CT vs MRI with pathology high and low risk and against outcomes
3 years after last recruit
To compare perioperative morbidity and mortality of patients staged by CT and MRI according to predicted prognostic risk.
Time Frame: 3 years after last recruit
Comparison of perioperative morbidity of patients stratified by preoperative treatment between patients staged with CT vs MRI
3 years after last recruit
To compare quality of life of patients staged by CT and MRI according to predicted prognostic risk.
Time Frame: 1 and 3 years after last recruit
Comparison of quality of life between patients staged with CT vs MRI by questionnaire (EORTC QLQ-CR29)
1 and 3 years after last recruit
To compare permanent defunctioning stoma rates in patients staged by CT and MRI according to predicted prognostic risk.
Time Frame: 3 years after last recruit
Comparison of proportion of stomas not reversed within 3 years postoperative follow-up in patients staged with CT vs MRI
3 years after last recruit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imperial College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pelican Cancer Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gina Brown, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DOCUMAS: 23HH8201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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